Trials that use: Non-inferiority trial design
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60 results
- ACTG A5279Independent statistical analysis of ACTG A5279 (NCT01404312), a randomized phase 3 trial comparing a rifapentine-plus-isoniazid regimen with an isoniazid regimen for tuberculosis prevention in people with HIV.
- Ad26.COV2.SIndependent statistical analysis of the phase 3 Ad26.COV2.S trial in healthy adults for COVID-19 prevention, including randomized design, influenza and SARS-CoV-2 immunogenicity endpoints, ANOVA, geometric mean ratios, non-inferiority, confidence intervals, and safety.
- ASPECCTIndependent statistical analysis of ASPECCT, the randomized phase 3 comparison of panitumumab and cetuximab in patients with KRAS wild-type metastatic colorectal cancer, including non-inferiority analysis, hazard ratios, response, patient-reported outcomes, and safety.
- ATLASIndependent statistical analysis of the phase 3 ATLAS trial of long-acting cabotegravir plus long-acting rilpivirine in HIV-1 infected adults, including non-inferiority design, Cochran-Mantel-Haenszel analysis, confidence intervals, and Week 48 results.
- ATMOSPHEREIndependent statistical analysis of the ATMOSPHERE phase 3 trial of aliskiren and aliskiren/enalapril in chronic heart failure, including trial design, time-to-event endpoints, Cox modeling, non-inferiority, superiority, safety, and interpretation.
- AWARD-6Independent statistical analysis of the randomized phase 3 AWARD-6 trial comparing dulaglutide with liraglutide in type 2 diabetes, including the HbA1c non-inferiority analysis, secondary endpoints, statistical methods, safety, and interpretation.
- BOLERO-6Independent statistical analysis of the BOLERO-6 phase 2 trial of everolimus plus exemestane versus everolimus alone and capecitabine in advanced breast cancer, including time-to-event methods, non-inferiority interpretation, quality-of-life analyses, and safety.
- CAPRISA 008Independent statistical analysis of CAPRISA 008, a randomized phase 2/3 trial evaluating 1% tenofovir gel provision through family planning services for HIV prevention, including adherence, HIV incidence, pregnancy, HPV, and safety analyses.
- CARMELINAIndependent statistical analysis of CARMELINA (NCT01897532), a randomized phase 4 trial of linagliptin versus placebo in patients with type 2 diabetes mellitus, including time-to-event methodology, non-inferiority testing, cardiovascular and renal endpoints, safety,…
- CAROLINAIndependent statistical analysis of the CAROLINA phase 3 trial comparing linagliptin with glimepiride in patients with type 2 diabetes, including non-inferiority testing, cardiovascular outcomes, glycaemic control, ANCOVA, Cox regression, and logistic regression.
- COAPTIndependent statistical analysis of the COAPT trial (NCT01626079), evaluating MitraClip in symptomatic heart failure with functional mitral regurgitation, including trial design, primary safety analysis, recurrent hospitalization, win ratio methodology, and statistical interpretation.
- COMPARZIndependent statistical analysis of the COMPARZ phase 3 trial comparing pazopanib with sunitinib in locally advanced and/or metastatic renal cell carcinoma, including its progression-free survival endpoint, non-inferiority framework, Cox model, and reported…
- DISCOVERIndependent statistical analysis of the DISCOVER phase 3 trial evaluating F/TAF versus F/TDF for HIV-1 pre-exposure prophylaxis, including non-inferiority testing, rate-ratio analysis, BMD, renal biomarkers, and statistical methodology.
- EINSTEIN-DVTIndependent statistical analysis of EINSTEIN-DVT, a randomized phase 3 trial of rivaroxaban versus enoxaparin followed by VKA in patients with venous thrombosis, including its non-inferiority analysis, Cox model, hazard ratio, confidence interval,…
- EINSTEIN-PEIndependent statistical analysis of EINSTEIN-PE, the randomized phase 3 trial of rivaroxaban versus enoxaparin followed by VKA in patients with acute symptomatic pulmonary embolism, including non-inferiority methodology, Cox analysis, hazard ratios, bleeding,…
- ELIXAIndependent statistical analysis of the ELIXA phase 3 trial of lixisenatide versus placebo in patients with acute coronary syndrome and type 2 diabetes, including its time-to-event endpoint, non-inferiority framework, hazard ratio, confidence…
- EMPA-REG OUTCOMEComplete statistical analysis of EMPA-REG OUTCOME, the randomized phase 3 trial of empagliflozin in patients with type 2 diabetes mellitus, including its time-to-event endpoints, Cox proportional-hazards analyses, non-inferiority framework, cardiovascular outcomes, microvascular…
- ENGAGE AF-TIMI 48Independent statistical analysis of ENGAGE AF-TIMI 48, evaluating edoxaban versus warfarin for stroke and systemic embolic events in patients with atrial fibrillation.
- ENVISAGE-TAVI AFComplete statistical analysis of ENVISAGE-TAVI AF, the randomized phase 3 trial comparing an edoxaban-based regimen with a vitamin K antagonist-based regimen in patients with atrial fibrillation after catheter-based heart valve replacement.
- EXSCELA detailed independent statistical analysis of EXSCEL, the phase 3 trial of exenatide once weekly versus placebo in patients with type 2 diabetes mellitus, including its randomized design, time-to-event endpoints, Cox models,…
- FLAMEIndependent statistical analysis of the FLAME phase 3 trial of QVA149 versus LABA/ICS in COPD, including exacerbation rates, time-to-event analyses, non-inferiority methodology, safety, and statistical interpretation.
- FLAMINGOComplete statistical analysis of the FLAMINGO phase 3 trial comparing dolutegravir with darunavir/ritonavir, each combined with dual NRTIs in ART-naive participants with HIV-1 infection.
- GALILEOComplete statistical analysis of the GALILEO phase 3 trial comparing a rivaroxaban-based antithrombotic strategy with an antiplatelet-based strategy after transcatheter aortic valve replacement, including endpoints, hazard ratios, confidence intervals, non-inferiority analysis, safety,…
- GOG-0252Independent statistical analysis of GOG-0252, a randomized phase 3 trial of bevacizumab with intravenous or intraperitoneal chemotherapy in patients with stage II-III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- GRIPHONIndependent statistical analysis of the GRIPHON phase 3 trial of selexipag in pulmonary arterial hypertension, covering its randomized time-to-event endpoint, secondary analyses, statistical methods, confidence intervals, and interpretation.
- GS-US-236-0102Independent statistical analysis of GS-US-236-0102, a randomized phase 3 trial comparing Stribild with Atripla in antiretroviral treatment-naive adults with HIV-1 infection, including the Week 48 virologic-success endpoint, non-inferiority framework, Wald/z-test methodology, and…
- GS-US-236-0103Independent statistical analysis of GS-US-236-0103 (NCT01106586), a randomized phase 3 study comparing Stribild with ritonavir-boosted atazanavir plus Truvada in antiretroviral treatment-naive adults with HIV-1.
- GS-US-292-0104Independent statistical analysis of GS-US-292-0104 (NCT01780506), a randomized phase 3 trial comparing E/C/F/TAF with E/C/F/TDF in antiretroviral treatment-naive adults with HIV-1 infection, including its non-inferiority analysis, risk difference, confidence interval, and Cochran-Mantel-Haenszel…
- GS-US-292-0109Independent statistical analysis of GS-US-292-0109 (NCT01815736), a randomized phase 3 trial evaluating switching from a TDF-containing regimen to E/C/F/TAF in virologically suppressed HIV-1-positive participants.
- HIMALAYAComplete statistical analysis of the phase 3 HIMALAYA trial of durvalumab and tremelimumab in advanced hepatocellular carcinoma, including trial design, overall survival, non-inferiority methodology, Cox regression, log-rank testing, and interpretation.
- Hokusai-VTEA complete statistical analysis of Hokusai-VTE, the randomized phase 3 trial comparing heparin/edoxaban with heparin/warfarin for symptomatic venous thromboembolism, including non-inferiority analysis, Cox modeling, bleeding outcomes, and statistical interpretation.
- IBCSG 23-01Independent statistical analysis of IBCSG 23-01, a randomized trial of axillary lymph node dissection versus no axillary lymph node dissection in women with node-negative breast cancer and sentinel lymph node micrometastases.
- KEYNOTE-062Independent statistical analysis of KEYNOTE-062, a randomized phase 3 trial of pembrolizumab monotherapy and pembrolizumab plus standard chemotherapy in advanced gastric adenocarcinoma, including survival, response, quality-of-life, and safety analyses.
- LEADERComplete statistical analysis of the LEADER phase 3 trial of liraglutide versus placebo in type 2 diabetes, including trial design, cardiovascular time-to-event endpoints, Cox regression, non-inferiority and superiority testing, secondary outcomes, safety,…
- ODINIndependent statistical analysis of the ODIN phase 3 trial comparing once-daily versus twice-daily darunavir/ritonavir in early treatment-experienced HIV-1 infected patients, including non-inferiority methodology, logistic regression, ANCOVA, Cox models, confidence intervals, and reported…
- PALOMA-3Independent statistical analysis of PALOMA-3, a randomized phase 3 study comparing lazertinib with subcutaneous amivantamab SC-CF versus intravenous amivantamab in participants with EGFR-mutated advanced or metastatic non-small cell lung cancer.
- PIONEER 6Independent statistical analysis of PIONEER 6, the randomized phase 3 trial of oral semaglutide versus placebo in subjects with type 2 diabetes, including its MACE endpoint, non-inferiority analysis, Cox model, hazard ratio,…
- PRoFESSAn independent statistical analysis of PRoFESS (NCT00153062), including its randomized double-blind design, recurrent-stroke endpoints, Cox proportional-hazards analyses, non-inferiority framework, hazard ratios, confidence intervals, and secondary outcomes.
- RATIONALE-301Independent statistical analysis of RATIONALE-301, a randomized phase 3 trial of tislelizumab versus sorafenib in participants with unresectable hepatocellular carcinoma, including overall survival, response, progression, quality of life, and the trial's non-inferiority…
- RE-COVER IIIndependent statistical analysis of RE-COVER II, a randomized phase 3 trial comparing dabigatran etexilate with warfarin for treatment of acute symptomatic venous thromboembolism, including non-inferiority and time-to-event analyses.
- RE-LYComplete statistical analysis of the RE-LY phase 3 trial of dabigatran versus warfarin, including randomized trial design, time-to-event endpoints, Cox proportional-hazards analyses, non-inferiority and superiority comparisons, safety, and statistical interpretation.
- RE-MODELComplete statistical analysis of the RE-MODEL phase 3 trial of dabigatran etexilate versus enoxaparin for prevention of thrombosis after knee surgery, including non-inferiority methodology, risk differences, confidence intervals, secondary endpoints, and safety.
- RE-NOVATEIndependent statistical analysis of the RE-NOVATE phase 3 trial comparing dabigatran etexilate with enoxaparin for prevention of venous thromboembolism following total hip arthroplasty.
- REMoxTBComplete statistical analysis of the REMoxTB phase 3 trial comparing two moxifloxacin-containing treatment-shortening regimens with a control regimen for pulmonary tuberculosis, including non-inferiority methodology, risk differences, confidence intervals, safety, and interpretation.
- ROCKET AFIndependent statistical analysis of ROCKET AF, the randomized phase 3 trial of rivaroxaban versus warfarin for prevention of stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation.
- SAILINGComplete statistical analysis of the SAILING phase 3 trial comparing GSK1349572 (dolutegravir) with raltegravir in antiretroviral-experienced, integrase inhibitor-naive adults with HIV infection, including its non-inferiority design, Cochran-Mantel-Haenszel analysis, risk difference, confidence interval,…
- SALSAIndependent statistical analysis of the phase 3 SALSA trial of switching to dolutegravir/lamivudine fixed-dose combination from a current antiretroviral regimen in virologically suppressed adults with HIV-1 infection.
- SHAPEIndependent statistical analysis of the SHAPE trial comparing radical versus simple hysterectomy with pelvic lymph node dissection for low-risk early stage cervical cancer, including its non-inferiority endpoint, time-to-event analyses, confidence intervals, and…
- SINGLEComplete statistical analysis of the SINGLE phase 3 trial comparing dolutegravir plus abacavir/lamivudine with Atripla in HIV-1 infection, including the Week 48 primary endpoint, later virologic suppression analyses, CD4 outcomes, non-inferiority methodology,…
- SPRING-2Independent statistical analysis of the SPRING-2 phase 3 trial comparing dolutegravir 50 mg once daily with raltegravir 400 mg twice daily for HIV-1 infection, including its non-inferiority design, stratified Cochran-Mantel-Haenszel analysis, confidence…